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BMJ No 7102 Volume 315

Letters Saturday 26 July 1997


Informed consent

Rigorous studies are needed to determine values of interventions

Editor,
Richard Smith's editorial and the accompanying papers concerning informed consent have considerable implications for research on the 'softer' areas of medicine.(1) There are important differences between trials looking at, say, distribution of an information leaflet or provision of a specialist nurse and studies of a new drug or of a surgical procedure.

If offered the choice of receiving an information leaflet or specialist nursing, few patients would opt for the equivalent of no treatment. Results from any such trial requiring informed consent would therefore be extremely unrepresentative and possibly misleading or meaningless.

In her commentary on Martin Dennis and colleagues' study Sheila McLean states: 'If certain research cannot be undertaken to the maximum standards of scientific inquiry the question is not how much information should be withheld, it is whether the research should be done in the first place.'(2) Many members of the legal profession, whose primary information base is case law, presumably hold this view. Medicine must, in contrast, be based on more than individual case histories.

As well as expecting to be kept informed by their doctors, patients expect their doctors to be informed. If we cannot perform rigorous studies we shall continue to be pressurised to provide interventions of little or no value to patients, and harm may result.

Richard Watson
General practitioner

11 Craigallian Avenue,
Glasgow G72 8DQ

Philip Wilson
General practitioner

148 Battlefield Road,
Glasgow G42 9JT

References

1 Smith R. Informed consent: the intricacies. BMJ 1997;314:1059-60. (12 April.)

2 Dennis M, O'Rourke S, Slattery J, Staniforth T, Warlow C. Evaluation of a stroke family care worker: results of a randomised controlled trial. [With commentaries by S McLean and M Dennis.] BMJ 1997;314:1071-7. (12 April.)


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